Cleared Traditional

TRC-NW400 NON-MYDRIATIC RETINAL CAMERA

K141481 · Topcon Corporation · Ophthalmic
Sep 2014
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K141481 is an FDA 510(k) clearance for the TRC-NW400 NON-MYDRIATIC RETINAL CAMERA, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Topcon Corporation (North Reading, US). The FDA issued a Cleared decision on September 17, 2014, 105 days after receiving the submission on June 4, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K141481 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2014
Decision Date September 17, 2014
Days to Decision 105 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120